1. Field of the Invention
The present invention is directed to a rotary seal stopper used in association with a container, such as a bottle or vial, for the containment and delivery of parenteral solutions, such as diagnostic contrast media and drug formulations. More particularly, the invention relates to a needleless access means having a rotatable seal therein for opening and closing the container for delivery of the parenteral solution to a site through luer connections.
2. Report Developments
There is an increasing worldwide demand for medical safety devices including safety syringes and other transfer devices. Needle stick injuries number about one million per year in the U.S. alone, resulting in thousands of hepatitis C infections.
The prior art has developed numerous devices to prevent accidental needle strike injuries to practitioners and patients. Such injuries are known to spread infectious diseases including hepatitis and AIDS. One of the main features of these devices is the lack of exposed sharp needles. The closures or stoppers have built-in access means to the content of the containers, such as vials, cartridges and bottles. The closures or stoppers in these devices serve the dual function of hermetically sealing the container while allowing safe access to the content therethrough.
Stopper systems for containers such as vials and bottles are made of materials that are resistant to chemicals and pharmaceuticals such as corrosive materials, reagents, parenteral solutions and solid formulations reconstitutable with a solvent prior to use. The most commonly used stopper/container system for such products has been glass or plastic bottles and vials equipped with stoppers made of elastomeric materials. The system provides for good hermetical seal, safe storage and easy access to the content through the elastomeric stopper via the use of an infusion spike or a syringe when withdrawal of the content is desired. The elastomeric stopper used generally comprises an elastomeric base, such as natural or synthetic rubber and an inert coating covering at least some portions of the stopper. The coating used includes chlorobutyl rubber, polymeric fluorocarbon resins such as polytetrafluoroethylene and various thermoplastic films. The coating is intended to insulate the elastomeric stopper base from the contents of the container in order to prevent contact and possible chemical reactions therebetween.
Generally, the elastomeric stopper is of cylindrical shape and has a flange head portion overlying the open top end of the container. Integral with the head portion is a body portion which extends into the open end and seated in the neck portion of the container, the diameter of the body portion being somewhat larger than the inside diameter of the container so that a tight seal is created between the body portion and the wall of the container. The lower end of the body portion is beveled towards the central, longitudinal axis of the body portion to facilitate the insertion of the body portion into the container. The circular bottom surface that faces the contents of the container is substantially planar and is imperforate, having no recess therein. The head portion of the stopper is provided with a central recess extending downwardly from the top thereof a substantial distance into the body portion so that the central recess and the circular bottom surface define a diaphragm. The walls forming the recess are generally cylindrical but may be provided with one or more circular protuberances extending inwardly to terminate just short of the center line of the stopper. The circular protuberances serve to press against and hold the needle of a syringe when the needle is inserted through the recess to penetrate the diaphragm for removal of the contents of the container. The elastomeric stopper is held in position by a metal ring or cap usually constructed of aluminum. The metal ring or cap has a removable center opening for allowing insertion of the syringe needle into the container.
Various stopper and access systems exist in the prior art to hold and remove the contents of containers which are illustrated hereunder.
U.S. Pat. Nos. 2,289,677 and 2,326,490 disclose a rubber stopper for use in vials comprising: an outer wall which serves as a seal between the vial and the stopper; and an inner wall forming a chamber in the center of the stopper, the bottom portion of the inner wall serving as a diaphragm. A hollow needle, having a sharp end for piercing the diaphragm, and an outer end exposed for connection with a syringe, is carried by the outer wall. A syringe connected to the outer end of the needle and pushed inwardly effects piercing of the diaphragm thereby permitting aspiration of the contents of the vial.
U.S. Pat. No. 2,342,215 discloses a dispensing and sealing stopper for a vial comprising: a stopper body having a hollow needle therein, one end of said hollow needle is in constant communication with the contents of the vial, and the other end is sealed by a penetrable, thin membrane. When withdrawal of the contents of the vial is desired, a syringe is inserted into the stopper to penetrate the thin membrane and to engage the other end of the hollow needle. When the syringe is removed, the thin membrane self-closes to maintain the hollow needle and the contents of the vial sterile.
U.S. Pat. No. 5,232,109 discloses an elastomeric stopper for a bottle, said stopper includes an annular protuberance which forms a second seal with the shaft of a spike inserted in the stopper to prevent leakage, blow-out and introduction of particulate matter into the fluid-containing bottle.
U.S. Pat. No. 5,364,386 relates to an infusion unit which comprises: a flexible, large container, a small medicine vial and a pipe which serves to communicate between the large, flexible container and the small medicine vial.
The large container is adapted to hold a solvent or diluent, while the medicine vial contains a powdery medicine which is to be mixed and dissolved in the solvent or diluent contained in the large, flexible container. Upon dissolution, the mixed medicine is discharged through an outlet at the lower end of the large container for infusion into a patient.
U.S. Pat. No. 5,429,256 pertains to a drug withdrawal system for a vial. The withdrawal system comprises: a vial containing a medicament therein and closed with a rubber gasket; and an apparatus which snap fits on top of the vial. The apparatus comprises: a chassis and a cap which is attached to the cap by a living hinge.
The chassis is cylindrical and has vertical grooves on the external sides to facilitate handling. The top of the chassis has a central opening. The chassis includes a male luer lock adapter having external threads thereon, and a ferrule structure the lower end of which has a hollow sharpened lance. The apparatus is used with a syringe having a female luer lock connector which snap fits with the male luer lock adapter.
In use, the cap cover is opened, and a syringe is screwed onto the outer end of the adapter. The syringe is then tightened on the adapter which moves the lance downward and the lance penetrates the gasket on the vial thereby establishing flow communication with the content of the vial. The content of the vial is withdrawn by pulling back on the plunger of the syringe. The syringe is then removed with the content therein ready to receive a needle assembly for injecting the content into a patient.
U.S. Pat. No. 5,433,330 relates to a needleless access stopper used on containers with a cannula having a blunt, stopper penetrating tip.
U.S. Pat. No. 5,921,419 discloses a closure assembly having an elastomeric membrane capable of being ruptured by a luer connector.
U.S. Pat. No. 5,971,181 discloses a multiple use universal stopper having an M-shaped clastomeric membrane capable of being ruptured by a luer connector, wherein the M-shaped elastomeric membrane reseals itself after being punctured by the luer connector.
The present invention provides sealing and access means for containers, such as bottles or vials made of glass or plastic containing medical fluids, such as x-ray contrast media and parenteral liquids. The access means provides for hermatic sealing, safe handling, sterilization and storing. The sealing means are designed for multiple use so that the medical fluid can be accessed repeatedly. After each withdrawal of the desired amount of the medical fluid, the access means is closed thereby preventing contamination of the medical fluid by air-born particles, such as dust and bacteria.
In accordance with one aspect of the present invention, a rotary seal stopper/container assembly is provided to allow access to a medical fluid contained in the container by the use of any external device that is equipped with a luer connector, such as syringe or cartridge barrels and IV sets.
In another aspect, the present invention provides a method for repeatedly accessing a medical fluid contained in a container equipped with the rotary seal stopper and closing the container after each use by rotating the rotary seal in order to prevent contamination of the medical fluid by air-born particles in the environment, such as dust and bacteria. The rotary seal stopper contains no xe2x80x9csharpsxe2x80x9d, such as sharp or blunt needle cannulas or spikes and, therefore, the use thereof does not have the risk of accidental injuries and transmittance of contagious diseases.
The rotary seal stopper/container assembly comprises:
a) a container, such as a vial, bottle, or a bag equipped with a rigid or semi-rigid exit port having an appropriate size sufficiently large to connectably receive the rotary seal stopper;
b) a rotary seal stopper assembled to the container; and
c) a removable cap covering the rotary seal stopper and the neck portion of the container or the neck portion of the rigid or semi-rigid exit port of a bag to maintain the rotary seal stopper in an aseptic condition prior to use.
The container used in conjunction with the present invention is made of glass or a polymeric material known in the art. When the container is made of glass it is in the shape of a vial or bottle. Plastic containers may be in the shape of a vial, bottle or bag. The vial or bottle is of rigid or semi-flexible polymeric material, while the bag is of a pliable polymeric material. In all the configurations the container is provided with a neck portion which is sufficiently rigid and is capable of retaining its dimensions when the rotary seal stopper is inserted thereinto. The container has a neck portion terminating in an open end to receive the rotary seal stopper which is inserted in the open end to seal the content therein and to maintain it in sterile condition.
The rotary seal stopper comprises:
an elastomeric stopper;
a thermoplastic rotary valve top insert; and
a thermoplastic rotary valve bottom insert, the rotary valve top and bottom inserts constituting the rotary valve. The rotary valve top insert is equipped with threads and thereby also serves as a male luer connector. The rotary valve is positioned into the elastomeric stopper such as by snapping the rotary valve into the elastomeric stopper. Alternatively, the rotary valve bottom insert may be shot molded into the elastomeric stopper followed by snapping the rotary valve top insert into the rotary valve bottom insert.
The elastomeric stopper having a head portion and a skirt portion is made of an elastomeric base, such as a natural or synthetic rubber preferably having an inert, polymeric coating thereon covering at least the medical fluid contacting portions of the stopper. Examples of elastomeric materials from which the stopper can be made include butyl rubber, isoprene rubber, silicone rubber, halogenated rubber and ethylene propylene therpolymer. Specific examples of a synthetic elastomeric rubber include: the CH2CF2xe2x80x94C3F6(C3F5H) and the C2F4xe2x80x94C2F3OCF3 series of elastomers made by DuPont under the tradenames of VITON(copyright) and CARLEZ(copyright); the fluoro-silicon rubbers, such as made by Dow Corning under the tradename of SILASTIC(copyright); and polyisobutylenes, such as VISTANEX MML-100 and MML-140; and halogenated butyl rubber, such as CHLOROBUTYL 1066 made by Exxon Chemical Company. These and other suitable elastomers may be made into the desired stopper configuration by known methods. Such methods typically include the use of a curing agent, a stabilizer and a filler and comprise a primary and a secondary curing step at elevated temperatures. The coating covering the elastomeric stopper may be of chlorobutyl rubber, polymeric fluorocarbon resins and thermoplastic films. The stopper is of cylindrical shape and has a flange head portion overlying the open top end of the container. Integral with the flange head portion is a skirt portion which extends into the open end and seated in the neck portion of the container. The inside diameter of the neck portion of the container is somewhat smaller than the outside diameter of the skirt portion so that a tight seal is created between the skirt portion and inside wall of the neck portion of the container. In the center portion of the stopper there is a cylindrical opening extending through the head and skirt portions of the stopper. The cylindrical opening is adapted to receive the rotary valve.
The rotary valve is made of thermoplastic materials such as polyethylene, polypropylene, polystyrene, polycarbonate, polymethylpentene, cyclic olefin polymers, acrylic polymers and methacrylic polymers.
A removable cap encloses the rotary seal stopper and the neck portion of the container. The cap is made of plastic, or a metal such as aluminum. The cap at its bottom portion is sealed to the neck of the container by a tear strip. At the point of use the tear strip is removed followed by removal of the cap revealing the male luer connector with locking threads thereon. A female luer connector is then attached and the contents of the container is delivered to the patient via a tubing and catheter.
The method of accessing a medical fluid contained in a container equipped with the rotary seal stopper of the present invention comprises the steps of:
a) providing the rotary seal stopper/container assembly as described herein;
b) removing the tear strip and the removable cap thereby exposing the male luer connector in the rotary seal stopper;
c) attaching an external access means having a female luer connector to the male luer connector of the rotary seal stopper;
d) turning the rotary seal top insert in the rotary seal stopper to the open position; and
e) delivering the medical fluid contained in the container to a patient.